FDA Approves Dangerous Gardasil Vaccine for Adults in the U.S.

by Brian ShilhavyEditor, Health Impact News

Following a June, 2018 “Priority Review” by the FDA to approve Merck’s Gardasil 9 vaccine to be expanded to women and men, ages 27 to 45, after 10 years of the FDA denying Merck’s request to expand the Gardasil market to adults, the FDA approved Gardasil 9 to be expanded to adults, aged 27 to 45, on October 8, 2018.

Granting approval to a vaccine after a “Priority Review” by the FDA in only 3 months is a “fast nod” according to FiercePharma, the market trade publication of the pharmaceutical industry.

Merck did not even have to supply any new trials or data to get the vaccine approved for adults, in spite of the fact that the FDA denied their request for 10 years on the older Gardasil vaccine. According to FiercePharma:

Because Gardasil 9 and sister shot Gardasil are manufactured similarly, the FDA based the Gardasil 9 decision on results from a study of its predecessor.

The study the FDA relied upon to approve Gardasil 9 for adults was considered insufficient for 10 years as the FDA denied Merck approval to market the vaccine to adults:

Back in 2008, after agreeing to a faster review in the age group, the FDA decided against Merck’s case for an additional Gardasil approval in females 27 to 45. The agency in 2009 issued a second complete response letter for that application, demanding Merck to provide longer-term efficacy data in the age group.

That set of data apparently didn’t turn things around for Merck. In both Gardasil’s and Gardasil 9’s current labels, information about a study on 3,253 women 27 through 45 years of age states that there was “no statistically significant efficacy” demonstrated by the vaccine in preventing high-grade cervical lesions or cervical cancer. (Source.)

Yet somehow, that same study is now deemed to be sufficient to approve Gardasil 9 for adults.

Why Did the FDA Approve This Vaccine?

The U.S. market for Merck’s Gardasil vaccine is declining, due to widespread information about the horrible side effects of the vaccine, which has been proven to cause autoimmune diseases, infertility, heart disease (POTS), and death, to name a few.

The pharmaceutical giant got a huge boost for its HPV vaccine earlier this year when it was approved for sale in China. See:

In other countries where Gardasil has been approved for years, such as Japan, government health agencies and consumer advocacy groups are backing away from their recommendation of Gardasil due to the numerous lives that have been destroyed by it.

The same month (June, 2018) that the FDA granted Merck its “Priority Review” to expand the Gardasil 9 vaccine market to adults, a study was published in the Journal of Toxicology and Environmental Health that looked at declining fertility rates among eight million U.S. women, aged 25 to 29, during a 7-year period.

The title of the study, published by Gayle DeLong, Ph.D., from the Department of Economics and Finance, Baruch College/City University of New York, is “A lowered probability of pregnancy in females in the USA aged 25–29 who received a human papillomavirus vaccine injection.”

This study analyzed information gathered in National Health and Nutrition Examination Survey, which represented 8 million 25-to-29-year-old women residing in the United States between 2007 and 2014.

Approximately 60% of women who did not receive the HPV vaccine had been pregnant at least once, whereas only 35% of women who were exposed to the vaccine had conceived.

Using logistic regression to analyze the data, the probability of having been pregnant was estimated for females who received an HPV vaccine compared with females who did not receive the shot.

Results suggest that females who received the HPV shot were less likely to have ever been pregnant than women in the same age group who did not receive the shot. If 100% of females in this study had received the HPV vaccine, data suggest the number of women having ever conceived would have fallen by 2 million. (emphasis added)

With Gardasil 9 now approved for both men and women between the child-bearing ages of 27 to 45, what effect will this have on U.S. fertility rates?

Merck Currently Fighting Vaccine Fraud Cases in Court

The FDA’s approval of Gardasil 9 for adults comes at a time when Merck is fighting vaccine fraud cases in court, including a lawsuit claiming that Gardasil’s original approval was based on fraudulent research.

16-year-old Jennifer Robi allegedly received three injections of the Gardasil vaccine between 2010 and 2011, and then later received the diagnosis of Postural orthostatic tachycardia syndrome (POTS).

Jennifer and her family filed a claim with the U.S. Vaccine Court. The court awarded her $38,365.08 in damages. (Source.)

The family was apparently not satisfied with this settlement, however, and on July 27, 2016, they filed a lawsuit in the Superior Court of The State of California, Los Angeles County.

The complaint outlined the fact that the Plaintiff and her family believed that Merck had wrongfully and deceitfully failed to perform in the preapproval processing period and thereafter, the material scientific and medical investigations and studies relating to the safety, effectiveness and need for the Gardasil vaccine as required by and under the FDA directives and regulations.

“Upon approval by the FDA of the Gardasil vaccine, Defendants Merck, Does 1 through 25, and each of them commenced and engaged in highly extensive, and aggressive marketing practices, which were designed primarily, if not solely, to increase the sales and profits from Gardasil.

In doing so, Defendants Merck, Does 1 through 25, and each of them, in order to preclude any and all questions by consumers, patients and others, as to the effectiveness, safety and need for the administration of the Gardasil vaccination as well as the risks of serious adverse reaction related thereto, intentionally, wrongfully and deceitfully withheld, failed to provide and concealed from consumers, patients and others material facts and information with respect to the effectiveness, safety and need for the administration of the Gardasil vaccination, as well as the risks of serious adverse reaction related thereto and as in part hereafter set forth.” (own emphasis)

In addition to this lawsuit, Merck is currently embroiled in an 8-year legal battle brought forth by their own scientists in a whistle-blower lawsuit claiming Merck also committed fraud in developing the MMR vaccine. See:

In France, Dr. Dalbergue, a former pharmaceutical industry physician with Gardasil manufacturer, Merck, has stated :

I predict that Gardasil will become the greatest medical scandal of all times because at some point in time, the evidence will add up to prove that this vaccine, technical and scientific feat that it may be, has absolutely no effect on cervical cancer and that all the very many adverse effects which destroy lives and even kill, serve no other purpose than to generate profit for the manufacturers. (Source.)

As possibly a result of this negative press in France, the French National Agency for Medicines and Health Products Safety, which is part of the European Medicines Agency, which works hard to promote vaccines, participated in a study to examine whether or not the HPV vaccine had an “increased risk of autoimmune diseases.”

The title of the study, published in August of 2017, was titled: Human papillomavirus vaccination and risk of autoimmune diseases: A large cohort study of over 2 million young girls in France.

As a pro-vaccine government agency, it is to be expected that the study would have a primary emphasis to do “damage control” to the negative public perceptions regarding the HPV vaccine and reassure the public that the vaccine was safe.

It is somewhat surprising, therefore, that the study raised any safety issues at all. They admitted that Guillain-Barré syndrome (GBS), a crippling condition similar to polio, had a significantly higher rate among those vaccinated with the HPV vaccine compared to those who were not.

Another study published around the same time (July 2017) was conducted by doctors in Mexico at the National Institute of Cardiology.

The study pointed out several areas of concern and discrepancies, including a safety report by The European Medicines Agency.

The results of their study found:

The lack of inert placebo in the vast majority of prelicensure HPV vaccine randomized studies

Julie Gerberding was in charge of the CDC from 2002 to 2009, which includes the years the FDA approved the Merck Gardasil vaccine.

Soon after she took over the CDC, she reportedly completely overhauled the agency’s organizational structure, and many of the CDC’s senior scientists and leaders either left or announced plans to leave. Some have claimed that almost all of the replacements Julie Gerberding appointed had ties to the vaccine industry.

Gerberding resigned from the CDC on January 20, 2009, and took over as the president of Merck’s Vaccine division, a 5 billion-dollar-a-year operation, and the supplier of the largest number of vaccines the CDC recommends (article here).

It was reported in 2015 that Dr. Gerberding, now the executive vice president of pharmaceutical giant, Merck, sold 38,368 of her shares in Merck stock for $2,340,064.32. She still holds 31,985 shares of the company’s stock, valued at about $2 million.

Besides examples like this showing a clear conflict of interest between government agencies tasked with overseeing public health and vaccine safety and pharmaceutical companies, the National Institute of Health also holds patents on vaccines such as Gardasil, and earns royalties from the sale of vaccines.

With the FDA’s approval of the Gardasil 9 vaccine for adults now, the government stands to earn even more revenue from this vaccine, as insurance companies and Medicare can now start picking up the cost of the vaccine.

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